MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 199721000

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is j&j company representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported during a spine fusion procedure on (b)(6) 2020, the verse correction key stripped.The procedure was a l5-s1 spondylodesis surgery using the verse system and conduit t-lif cage.The surgeon fixated the rods on s1 with verse unitized set screws, on l5 with the verse key on both sides.Distraction of the segment and tightening first the outer, then the inner setscrews occurred on l5.The cage was implanted.Fixation of the rods also occurred as per surgical technique.While loosening the distraction of the area, and during the final tightening of both outer and inner set screws, the inner setscrew l5 on the right side could not be tightened, was turning loose.The setscrew was removed and replaced by a new one.The removed setscrew was stripped and damaged.The procedure was completed with a 5 minute surgical delay.Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: unknown).Unknown cage (part#: unknown, lot#: unknown, quantity: unknown).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: a.Patient information.D4: expire date & lot number provided for reporting.D9: the device has been received.D11: concomitant products added.H3, h4, h6, device history lot the dhr of product code 199721000, lot 251765, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on july 26, 2019.Qty.(b)(4).The dhr was electronically reviewed.H6: investigation summary: background: crushed/stripped verse dual innie correction key 199721000 in spondyloses surgery l5s1 with verse system and conduit t-lif cage.Fixation of the rods on s1 with verse unitized set screws, on l5 with 199721000 on both sides.Distraction of the segment and tightening first the outer, then the inner setscrews on l5.Implantation of the cage.Then loosening of the distraction and final tightening of both outer and inner set screws.At this maneuver the inner setscrew l5 on the right side could not be tightened, was turning loose.Removal of the setscrew 199721000 and replaced by a new one.The removed setscrew was stripped and hurt concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).Unknown cage (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the verse correction key (part #: 199721000, lot #: 251765) was received at us cq.Upon visual inspection, the rod lock component was observed to be broken.No other defects were identified on the device.Device failure/defect was identified.Dimensional inspection: no dimensional inspection was done due to post manufacturing damage identified.Document/specification review: the following drawings were reviewed; dwg-887010006 rev e/ d; dwg-887010008 rev b.No design issues or discrepancies were identified.Complaint not confirmed.Investigation conclusion: this complaint is not confirmed as the complaint device verse correction key (part #: 199721000, lot #: 251765) was received with the broken rod lock component.No definitive root cause could be determined based on the information provided but it is likely that the device experienced excessive forces.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D4: expire date & lot number provided for reporting.E1: reporters state: solothurn.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10726142
• MDR Text Key: 228169381
• Report Number: 1526439-2020-02023
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034466132
• UDI-Public: (01)10705034466132
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 251765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 09/26/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/30/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN CAGE/SPACER.; UNKNOWN CAGE/SPACER.; UNKNOWN RODS.; UNKNOWN RODS.; VERSE CORRECTION KEY.
• Patient Age: 75 YR
• Patient Weight: 90